Empaveli 1,080 mg/20 mL subcutaneous solution

Generic name:
Pegcetacoplan - subcutaneous injection

Pronunciation
(peg-SET-a-KOE-plan)

Brand name(s)
Empaveli

Pegcetacoplan can lower your body's ability to fight infections. This increases your chance of getting very serious (possibly fatal) infections (especially meningitis or sepsis). Get medical help right away if you develop symptoms such as nausea/vomiting that doesn't stop, fever, chills, severe headache, stiff neck, mental/mood changes (such as confusion), muscle aches with flu-like symptoms, eye sensitivity to light.

Your doctor may prescribe certain vaccines for you to get at least 2 weeks before receiving this medication. Vaccines may not fully protect everyone who receives them, so you should still watch for signs of infection after you get the vaccine.

To receive pegcetacoplan in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Pegcetacoplan is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to destroy red blood cells, which results in anemia. It works by helping block your body's destruction of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath), and may reduce the need for blood transfusions.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using pegcetacoplan and each time you get a refill. Carry the Patient Safety Card with you at all times during treatment and for 2 months after your last dose of pegcetacoplan. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

This medication is given by slow injection under the skin as directed by your doctor, usually twice a week. The injection is given using an infusion pump in the abdomen, thighs, hips, or upper arms. The dosage is based on your medical condition, lab tests, and response to treatment.

Take the medication out of the refrigerator 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. If more than one site is needed for your dose, make sure they are at least 3 inches apart. Do not infuse into skin that is tender, bruised, red, or hard, or has tattoos, scars, or stretch marks. To lessen bruising, do not rub the injection site after each dose. Learn how to store and discard medical supplies safely.

Infusion reactions may happen during the infusion of this drug. Tell your doctor right away if you have any symptoms of infusion reactions such chest discomfort/pain, shortness of breath, feeling faint, or injection site itching, warmth, redness, swelling, rash, or pain.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder. If you are changing to this medication treatment from another drug, carefully follow your doctor's directions for when to start or stop this and your other medication(s). Do not stop using this medication without consulting your doctor. Your condition may become worse when the drug is stopped. If you do stop using this medication, your doctor will monitor you for at least 8 weeks to make sure your condition does not get worse. Consult your doctor for more details.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning and How to Use sections.

Tiredness, headache, dizziness, diarrhea, abdominal pain, or muscle/joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using pegcetacoplan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent infection
• vaccinations

Pegcetacoplan can make you more likely to get certain infections (such as flu, colds, meningitis). Talk to your doctor for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using pegcetacoplan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using pegcetacoplan. Pegcetacoplan may harm an unborn baby. Your doctor may order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 40 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 40 days after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as LDH levels, complete blood count) should be done while you are using this medication and for at least 8 weeks after stopping treatment. Keep all medical and lab appointments.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator. Keep the medication in the original container to protect from light. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.